Kornimate/medical-research-clean huggingface dataset:
reproducibility of nerve fiber layer thickness measurements in patients with glaucoma and healthy controls using spectral-domain and time-domain oct

Conditions: Glaucoma Patients and Healthy Controls

Summary: to assess the reproducibility of spectral-domain-oct (sd-oct) retinal nerve fiber layer thickness (rnfl) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional time-domain-oct (td-oct). * trial with medical device


Eligibility criteria:
inclusion criteria: control group: age 18yo or older, healthy glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (poag) exclusion criteria: exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmhg. exclusion criteria in the glaucoma group were history of other optic neuropathies. or severe optic media opacities.
chinese validation of the simplified evaluation of consciousness disorders（seconds）

Conditions: Brain Diseases; Vegetative State; Unconsciousness; Central Nervous System Diseases

Summary: the aim of this study was to translate the seconds from french into chinese and assess the validity and reliability of the chinese version of the seconds .

to promote accurate assessments of doc patients and the development of clinical research on doc in china, we here propose and validate a version of the seconds translated into mandarin chinese. hence, this study aims to assess the concurrent validity (compared with the crs-r which has already been translated and validated in mandarin), intra-rater reliability, and inter-rater reliability of the chinese version of the seconds

Eligibility criteria:
inclusion criteria: * acute (longer than 14 days, less than 28 days) or prolonged doc (following severe acquired brain injury, longer than 28 days); * age: 18-85 years old; * no history of other neurological or psychiatric deficits; * ability to speak chinese fluently; * medical stability (e.g., absence of mechanical ventilation, sedation, infection) exclusion criteria: * none

Keywords: coma disorder of consciousness behavioral scale rehabilitation diagnosis
inflammatory local response during olv: protective vs conventional ventilation strategy

Conditions: Ventilator-Induced Lung Injury; Inflammatory Response; Respiratory Complication

Summary: this study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. we compare two different ventilation strategies: a conventional strategy with a protective strategy.

one-lung ventilation (olv) is a ventilation procedure used for pulmonary resection often causing lung injury. international guidelines have recommended for years the use of conventional ventilation (cv) with high tidal volume (vt) (8-10 ml\\kg).a body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. in this study we compare the conventional strategy , consisted of vt 10 ml/kg, with the protective strategy, consisted of vt 5 ml/kg. both vt were based on predicted body weight (pbw). broncho-alveolar lavages (bal) are selectively performed in the dependent (ventilated) lung before and at the end of the olv. the levels of pro-inflammatory (il-1α, il-1β, il-6, il-8, tnf) and anti-inflammatory (il-2, il-4, il-10, infγ) cytokines are evaluated. we also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.

Eligibility criteria:
inclusion criteria: * patients undergoing elective lobectomy and wedge resection exclusion criteria: * emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ asa iv

Keywords: one-lung ventilation broncho-alveolar lavage protective ventilation cytokines thoracic surgery
prevalence of lysosomal hydrolase alpha-glagtosidase deficiency in patients with antiphospholipid syndrome.

Conditions: Antiphospholipid Syndrome

Summary: fabry disease, an x-linked disorder of glycosphingolipids that is caused by mutations of the gla gene that codes for α-galactosidase a, leads to dysfunction of many cell types and includes a systemic vasculopathy. as a result, patients have a markedly increased risk of developing ischemic stroke, small-fiber peripheral neuropathy, cardiac dysfunction and chronic kidney disease. because this disease is a rare disease most of the time it is misdiagnosed, so in this study we will check out the prevalence of lysosomal hydrolase alpha-glagtosidase deficiency ( fabry disease) in patients with antiphospholipid syndrome.

the investigators would like to assess the prevalence of fabry in men and women aged 18-100 who were diagnosed with antiphospholipid syndrome in our departmental clinic in 2000-2017 it is very important to diagnose fabri that then the treatment of patients can vary dramatically. the study will include 100 adult patients (18-100) men and women. testing for the fabri test in men is an enzyme test and will be performed subject to their consent to sign informed consent. in the women, an enzyme test will be carried out, and the plasma lys-3-3 plasma storage, as recommended in the recently published diagnostic algorithms, is examined. if diagnosed, a patient will be referred to a genetic institute for further genetic counseling

Eligibility criteria:
inclusion criteria: * clinical diagnosis of antiphospholipid syndrome. * able to read and sign inform concent exclusion criteria: • fabry disease.
can prp reduce pro-inflammatory biomarkers following acl injury

Conditions: ACL - Anterior Cruciate Ligament Rupture; ACL Injury

Summary: the purpose of this single-center, double-blinded randomized control trial with prospective data collection is to assess the ability of platelet rich plasma (prp) treatment to reduce the level of pro-inflammatory synovial fluid biomarkers following an acute anterior cruciate ligament (acl) tear. the study will collect and analyze synovial fluid of patients presenting with an acute anterior cruciate ligament (acl) tear with a second synovial fluid sampling at the time of surgery. it will compare synovial fluid biomarker levels between those receiving an intra-articular platelet rich plasma (prp) injection versus an intra-articular saline injection serving as a control. post-operative clinical outcomes will also be assessed, including post-operative pain levels, incidence of post-operative knee stiffness and patient reported outcome scores.


Eligibility criteria:
inclusion criteria: * patients have suffered an acute acl tear (initial presentation within 7 days of injury) with or without an associated meniscus injury * patient must undergo acl reconstruction surgery exclusion criteria: * mentally impaired (e.g, alzheimer's subjects, dementia, etc.) * younger than 18 years of age * patients who have a multiligamentous injury * patients with underlying inflammatory arthropathies * previous acl injury and/or reconstruction

Keywords: platelet rich plasma
image-endocarditis: resonance magnetic imaging at the acute phase of endocarditis

Conditions: Endocarditis, Bacterial

Summary: patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.

patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease. resonance magnetic imaging (head and abdomen) will be performed systematically before day 7. the impact on the diagnosis and therapeutic options will be assessed, as compared to pre resonance magnetic nuclear (rmn) imaging declaration.

Eligibility criteria:
inclusion criteria: * acute phase of infective endocarditis exclusion criteria: * contra indication to rmn

Keywords: endocarditis rmi impact measure
nutritional problems in pallative cancer

Conditions: Lung Cancer; Pancreatic Cancer

Summary: the aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

this study will include a recruitment of 50 lung and pancreas cancer patients currently in chemotherapy. they will be observed during a period of 9-12 week, including at least 2 chemotherapy treatments. the presence and severity of the nutritional problems will be examined by observing as many different factors as possible. this includes taste alterations, weight changes, nutritional intake, physical activity, interviews and weekly questionnaires. in relation to this our primary outcome is to investigate the correlation between changes in taste and changes in nutritional intake. secondarily the investigators want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

Eligibility criteria:
inclusion criteria: * lung or pancreas cancer patient * in chemoterapy regardless of line treatment with/without combined treatment * legal age * able to speak and read in danish * ambulant exclusion criteria: * inability to give consent and complete questionnaires * participating in clinical interventions during the periode of observation * allergic to milk or for any reason don't consume diary products

Keywords: malnutrition cancer weight loss lean body mass
a.fib emergency department study atrial fibrillation

Conditions: Atrial Fibrillation

Summary: patients with a history of atrial fibrillation (af) who frequently attend the emergency department (ed) with symptoms may not require emergency treatment, and may be more appropriately managed in an alternative outpatient setting. this may be the result of inappropriate or inadequate advice or a lack of patient understanding. the main research objective pertains to the reason for seeking medical attention for af in the ed, ed management of the patient, outcomes of ed care and alternative strategies.

this study is a multi-centre, multi-provincial, patient survey using mixed methods. 778 patients will be enrolled from 9 centres in 3 provinces from academic, urban, and rural centres to achieve geographical and health system heterogeneity. the planned duration of the entire study (enrollment through follow-up) is approximately 12 months. patients presenting to the ed with a primary diagnosis of af and with a prior diagnosis of established af will be approached to participate. each centre will be responsible for obtaining local consent. data will be stored confidentially and securely at the coordinating centre (queens university, kingston, ontario). patients who meet the inclusion criteria will be invited to take part at the time of presentation to the ed or after their ed visit. for all enrolled patients, one follow up telephone call will be made within one to four weeks of the ed visit by a social scientist with specialised training in questionnaires based in queens university, kingston, ontario.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * atrial fibrillation is the primary reason for ed visit (documented by 12-lead ecg or holter rhythm strip by a member of the healthcare team providing care to the patient). * patients with an established history of af (prior diagnosis with ecg / rhythm strip evidence of af) * patient must be literate in english * patient must provide informed consent exclusion criteria: * male or female \< 18 years of age * non-english speaking * unable and/or unwilling to consent * acute coronary syndrome (ischemic chest pain, st changes, + troponin \[mild troponin elevation alone does not exclude the patient\]) * cardiogenic shock or class iv congestive heart failure at the time of visit * enrolled in a cardiovascular drug or device research study * new onset atrial fibrillation
comparison of a plant protein diet to a animal protein diet emphasized in type 2 diabetics

Conditions: Diabetes Mellitus, Type 2; Nutrition Disorders; Obesity; Body Weight; Metabolic Syndrome x; Metabolic Diseases

Summary: this 6-week parallel randomised prospective dietary intervention study with type 2 diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.

2x20 patients with diabetes mellitus type 2 are randomise by a blind computer assist for an equal allocation in both groups (animal protein vs. plant protein). the food components for both groups are 40% carbohydrates, 30% fat and 30% protein. the carbohydrates are correspond with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic index).

Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * hba1c between 6-11% exclusion criteria: * consumptive or high grade diseases * intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ass, antibiotics) * diabetes type 1 * pregnancy * chronic disease of heart, kidney, liver * high grade anaemia * high grade infection disease * relevant change of body weight (+/- 5 kg) since 8 weeks before begin of study intervention * missing data about primary outcome measures (hyperinsulinaemic euglycaemic clamp, mealtime test, data about dietary intake from food diaries or food protocols) * significant deviation from dietary targets during the monitored 6 weeks isoenergetic period * allergies including food allergies

Keywords: nutritional support diet therapy protein diet isocaloric diet
probiotic supplementation in the term newborns delivered by caesarean section

Conditions: Microbiota, Cesarean Section, Probiotics, Dysbiosis

Summary: objectives: the gut microbiota plays pivotal role in the maintenance of human health. there are numerous factors, including the mode of delivery, that impact early gut colonization. recent research focuses on probiotics' use in prophylaxy of gut dysbiosis in the newborns delivered by cs. we aimed to investigate whether a probiotic supplement in the newborns delivered by cs alter the pattern of gut colonization and has effect on decreasing risk of dysbiosis. methods: a prospective, randomized trial with a control group. 150 newborns, born in 38-40 gestational age, delivered by cs were included to the study. they were randomized into 2 groups- interventional supplemented with the probiotic containing bifidobacterium breve pb04 i lactobacillus rhamnosus kl53a (ffbaby, ibss biomed sa, poland) and control. stool samples were obtained on 5th and 6th day of life and after one month of life, and analyzed microbiologically in the lab. bacterial colonies' genre and species were next identified and quantified.

the aim of the study was to assess the effect of the probiotic supplementation on microbiota composition of the gut in healthy newborns delivered by cs. we studied colonization of gi tract on the day of discharge from hospital and after a month of life. it was a prospective, randomized trial with the control group, conducted in the neonatal clinic of the jagiellonian university hospital in kraków, lasting from april 2014 to april 2017. the patients we recruited were randomized into 2 groups- interventional or control group. in the interventional group we supplemented the probiotic containing bifidobacterium breve pb04 i lactobacillus rhamnosus kl53a (ffbaby, ibss biomed sa, poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 cfu bacteria). the permission for the clinical trial was granted by the regional medical bioethical committee of the jagiellonian university. (the number of decision- kbet/46/b/2014 from the 27th of march 2014)

Eligibility criteria:
inclusion criteria:38-40 gestational age, normal, healthy pregnancy, delivery by cs, good clinical condition after birth, apgar scale- 8-10 points, proper gestational mass\> 2500g, informed consent of parents. - exclusion criteria:conditions mentioned above were not fulfilled, lack of informed consent of the parents or their resignation from the study. -
cardiac output optimization on postoperative complications in major hepatic surgery

Conditions: Primary or Metastatic Hepatic Adenocarcinoma

Summary: major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. the 1st peroperative phase of "hepatic resection" requires a minimum supply of filling fluids to limit perioperative bleeding (low central venous pressure). however this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. on the other hand, the hemodynamic management of the 2nd peroperative phase "post hepatic resection" is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling. the major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the "post resection of the hepatic parenchyma" phase. our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the "post hepatic resection" phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, 2. signature of consent, 3. any patient scheduled for major hepatic surgery (≥ 3 segments) scheduled by laparotomy, for primary hepatic cancer or secondary metastases, 4. affiliation to the ''national security'' regimen or beneficiary of this regimen. exclusion criteria: 1. emergency surgery, 2. cirrhosis: depending on availability of ct and / or mri imaging results, clinical examination, biology (pt, bilirubin) or histological results (preoperative biopsies in healthy liver) 3. portal hypertension: depending on availability of imaging data, history of esophageal varices 4. contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal doppler for example), 5. benign tumors, 6. associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic), 7. laparoscopy, 8. liver transplantation, 9. woman pregnant or likely to be (without effective contraception) or breastfeeding, 10. person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent, 11. inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
3d team care for cognitively vulnerable older adults

Conditions: Dementia; Depression; Delirium

Summary: this study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3ds). the investigators will test the effectiveness of a team care model focused on the 3ds (home based care team) guided by nurse practitioners with expertise in geriatrics and geriatric psychiatry. specific aims are to determine home based care team effects on hospitalization or emergency department use, and other outcomes including depression, disability, and quality of life.

this study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3ds). cognitive vulnerability in older adults is often overlooked by primary care and hospital-based providers, and represents a marker for overall vulnerability or frailty often missed when disease-specific approaches are emphasized in the care for older adults. such patients often cannot adequately self-manage their comorbidities. many studies of older adults and their families have demonstrated the great burden of living with cognitive vulnerability. the investigators will test the effectiveness of a team care model focused on the 3ds (home based care team) guided by nurse practitioners with geriatrics expertise. other team member disciplines will include pharmacy, social work, occupational and physical therapy, nutrition, and community health worker. long-term objectives are to determine whether this care model can become a widely available approach for improving healthcare systems for older adults with cognitive vulnerability and their families, while improving outcomes of importance to these patients and families. a project steering committee, including cognitively vulnerable patients and family caregivers, will provide extensive input into many aspects of the research process.

Eligibility criteria:
inclusion criteria: * evidence of dementia, depression, and/or delirium, based on diagnostic codes found in medical claims data and based on screening at time of study screening. * living in the community, including assisted living facility, at time of randomization * plan to live in geographic area for 12 months * speak or understand english * willing to be randomly assigned to intervention or active comparator group exclusion criteria: * diagnosed schizophrenia or bipolar disorder * bedbound and non-communicative * life expectancy \<12 months * already enrolled in active comparator program * for individuals with dementia, family caregiver is unavailable or unwilling to enroll in study

Keywords: older adults family caregivers medicare advantage beneficiaries